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Sponsored by: |
Elan Pharmaceuticals |
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Information provided by: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00056576 |
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
Condition | Intervention | Phase |
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Epilepsy, Complex Partial |
Drug: Zonisamide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized, Multicenter, Parallel Group Study to Establish Dose-Response, Safety, and Efficacy of Zonegran (Zonisamide) as Monotherapy in Patients With Newly Diagnosed Epilepsy |
Estimated Enrollment: | 165 |
Study Start Date: | February 2002 |
Epilepsy is characterized by repeated seizures caused by recurrent, abnormal, and excessive synchronous discharges from cerebral neurons. Seizures may be triggered by various causes such as CNS infections, fever, tumors, toxins, vascular disease, degenerative disease, trauma, or may be idiopathic. The type of seizure is usually defined by the initial event, the duration, alterations of consciousness, patterns of motor activity, and post-ictal symptoms. In addition, certain seizure types have characteristic EEG patterns. The International Classification of Epileptic Seizures classifies seizures as partial or generalized. Partial seizures are further classified as simple partial, complex partial (impaired consciousness), or partial seizures secondarily generalized. All partial seizures have onset in a discrete cortical region. Generalized seizures are bilaterally symmetrical and without focal onset and include absence seizures, myoclonic seizures, clonic seizures, tonic seizures, tonic-clonic seizures, and atonic seizures. The goals of treatment include the prevention of seizures, medical management of seizures, and management of the consequences of epilepsy. The study will be conducted with patients who have new onset epilepsy characterized by complex partial seizures and will attempt to characterize the relationship between zonisamide dose and seizure prevention and demonstrate monotherapy efficacy.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EEG changes consistent with the diagnosis of epilepsy:
EXCLUSION CRITERIA
Study ID Numbers: | AN46046-304 |
Study First Received: | March 18, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00056576 |
Health Authority: | United States: Food and Drug Administration |
Monotherapy Complex Partial Seizures Epilepsy anti-epilepsy drug AED |
Epilepsies, Partial Epilepsy, Complex Partial Epilepsy Zonisamide |
Seizures Central Nervous System Diseases Brain Diseases |
Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Agents Protective Agents Anticonvulsants Pharmacologic Actions |